This invention relates to a method for chemically debriding abnormal, damaged or necrotic tissue which is related to that claimed in my U.S. Pat. No. 4,497,824, whose disclosure is incorporated herein by reference.
The treatment topically of traumatized or pathological areas of the body having abnormal ischemic tissue around or covering a lesion is often hampered by the fact that the ischemic tissue presented by the affected area provides a pathological surface which is an effective barrier between normal tissue and the natural healing process or a healing agent employed to thereby initiate the healing process. In such cases, physicians sometimes resort to the very painful task of manually debriding the abnormal tissue or covering the area with bandages soaked in medication to prevent infection while keeping the surface moist. Both of these approaches have obvious limitations and pose well known problems.
There therefore is a long-standing need for an effective chemical debriding agent. There is also a need for a non-toxic, non-allergenic bacteriostat and fungistat which is also effective in promoting the normal healing of traumatized or pathological epithelium by suppressing infection and/or the natural inflammatory process.
The compositions employed in the method claimed in U.S. Pat. No. 4,497,824 comprise biphenamine ( -diethylaminoethyl 3-phenyl-2-hydroxybenzoate) base or pharmaceutically acceptable acid addition salt thereof. Salts of this compound are known to have a variety of activities, including local anesthetic (U.S. Pat. No. 1,976,922); treatment of seborrhea capitis in a shampoo (U.S. Pat. No. 3,123,531); as well as antihistaminic and bactericidal activity and fungicidal properties (U.S. Pat. No. 2,594,350; Report Annual Meeting So. Med. Assoc., Nov. 6, 1961).
Biphenamine hydrochloride has been sold as a 1% ointment, under the trademark "Melsaphine", as a topical anesthetic agent possessing bactericidal, fungicidal and antihistamine properties and as a 1% aqueous shampoo under the trademark "Alvinine", Federal Register, Vol. 34, No. 189, page 153, Oct. 2, 1969. See also U.S. Pat. No. 3,123,531.
Although its use in a shampoo for treating seborrhea and related conditions is claimed in U.S. Pat. No. 3,123,531, nothing was known concerning its ability to promote the healing of traumatized or pathological epithelium.
The method of this invention also employs aloe vera. (As used herein, the term aloe vera means the viscous, sticky juice of the aloe vera plant.) Although aloe vera does not itself debride, it stimulates wound healing and inhibits the formation of granulation tissue.
The juice from the aloe vera plant has been used as a home remedy for minor burns to reduce the pain and the inflammation associated therewith. The use of biphenamine and aloe vera in combination has proved to be especially effective in debriding and stimulating wound healing.
The topical compositions employed in the method of this invention optionally also comprise, especially when the lesion is epithelial, an amount of a skin penetrant, e.g., DMSO (dimethyl sulfoxide) or propylene glycol, which by itself has no debriding or wound healing enhancement effects, at least in the amount employed. U.S. Pat. Nos. 3,551,554 and 3,711,602 disclose that DMSO is effective as an agent for enhancing tissue penetration of physiologically active agents. U.S. Pat. No. 3,549,770 discloses (Example 36) the topical application of a mixture of acetylsalicyclic acid and DMSO is more effective than DMSO alone to relieve the pain and muscle spasm of rheumatoid spondylitis. See also U.S. Pat. Nos. 3,711,602; 3,711,606; and 3,743,727 and references cited therein. These patents disclose that the tissue penetration of physiologically active compounds, inter alia, steroidal agents and certain antimicrobial agents, can be enhanced by DMSO. U.S. Pat. No. 3,740,420 discloses DMSO compositions for topical administration containing thickening agents.